SCOPUS 정보 검색 플랫폼

JAMA - Journal of the American Medical Association

Volumn 313, Issue 7, 2015, Pages 667-668

FDA regulation of laboratory-developed diagnostic tests: Protect the public, advance the science

(1) Sharfstein, Joshua a

a Department of Health and Mental Hygiene ^* (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL EFFECTIVENESS; DIAGNOSTIC PROCEDURE; FALSE POSITIVE RESULT; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HOSPITAL LABORATORY; HUMAN; LABORATORY DIAGNOSIS; MEDICAL SOCIETY; NOTE; PRIORITY JOURNAL; QUALITY CONTROL; RISK BENEFIT ANALYSIS; SAFETY; UNITED STATES; VALIDITY; STANDARDS;

CLINICAL LABORATORY TECHNIQUES; GOVERNMENT REGULATION; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84923197673 PISSN: 00987484 EISSN: 15383598 Source Type: Journal
DOI: 10.1001/jama.2014.18135 Document Type: Note

Times cited : (30)

References (6)

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- Concerns regarding a new culture method for Borrelia burgdorferi not approved for the diagnosis of Lyme disease
- Nelson C, Hojvat S, Johnson B, et al; Centers for Disease Control and Prevention (CDC). Concerns regarding a new culture method for Borrelia burgdorferi not approved for the diagnosis of Lyme disease. MMWR Morb Mortal Wkly Rep. 2014;63 (15):333.
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- Nelson, C.¹ Hojvat, S.² Johnson, B.³

2
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- FDA website. Accessed December 9
- US Food and Drug Administration. (FDA). Laboratory Developed Tests. FDA website. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm407296.htm. Accessed December 9, 2014.
- (2014) Laboratory Developed Tests

3
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- 21 USC 321 (h). Section 201, Chapter II-Definitions. Accessed December 22
- US Food, Drug, and Cosmetic Act, 21 USC 321 (h). Section 201, Chapter II-Definitions. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/ucm086297.htm. Accessed December 22, 2014.
- (2014) US Food, Drug, and Cosmetic Act

4
- 84923054569
- October 3, 2014. Accessed December 9
- US Food and Drug Administration (FDA). Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM416685.pdf. October 3, 2014. Accessed December 9, 2014.
- (2014) Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)

5
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- The KIF6 collapse
- Topol EJ, Damani SB. The KIF6 collapse. J Am Coll Cardiol. 2010;56(19):1564-1566.
- (2010) J Am Coll Cardiol. , vol.56 , Issue.19 , pp. 1564-1566
- Topol, E.J.¹ Damani, S.B.²

6
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- Princeton, NJ: Princeton University Press
- Carpenter D. Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Princeton, NJ: Princeton University Press; 2010.
- (2010) Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA
- Carpenter, D.¹

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.